FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Sealant, Polymerizing
PMA: P060029
·
Supplement: S005
·
Decision Jan 17, 2014
Classifications
1
FEI Numbers
15
Registration Numbers
15
Basic Information
- Device Name
- Sealant, Polymerizing
- Trade Name
- ETHICON OMNEX SURGICAL SEALANT
- PMA Number
- P060029
- Supplement Number
- S005
- Device Class
- FDA Class 3
- Product Code
- NBE
- Generic Name
- Sealant, polymerizing
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- January 17, 2014
- Date Received
- January 8, 2013
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A MANUFACTURING SITE LOCATED AT ETHICON, INC., IN CORNELIA, GEORGIA.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NBE | Sealant, Polymerizing | FDA class 3 | Unknown |